ff49699c-ced9-13d2-e053-6394a90af079

SPL v2
SPL
SPL Set ID ff49699c-ced9-13d2-e053-6394a90af079
Route
topical
Published
Effective Date 2023-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (6 g)
Inactive Ingredients
calendula officinalis whole camphor (natural) carbomer 980 ilex paraguariensis leaf melissa officinalis leaf phenoxyethanol aloe vera leaf cannabidiol glycerin isopropyl alcohol camellia sinensis whole frankincense fd&c blue no. 1 fd&c yellow no. 5 isopropyl myristate .alpha.-tocopherol acetate trolamine water arctium lappa root arnica montana flower silicon dioxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-08-19

Description

Menthol ................ 6%


Medication Information

Warnings and Precautions

For external use only

Active Ingredient

Menthol ................ 6%

Indications and Usage

Temporary relief from minor aches and pains of muscles and joints associated with arthritis,simple backache,strains and sprains.

Dosage and Administration

Directions: Adult and children 2 years of age and older. Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age consult a physician

Description

Menthol ................ 6%

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center immediately

Section 50566-9

Stop use and ask doctor if condition worsens or symptoms persist for more than 7 days, or clear up and reoccur a gain within few days.

Section 50567-7

When using this product • avoid contacts with the eyes Of mucous membranes • do not apply to wounds or damaged skin • do not apply to irritated skin • do not bandage • wash hands after use with cool water • do not use with heating pad or device.

Section 51727-6

Inactive ingredients /Joo Barbadensis Leaf Extract,Arcium Lappa Roof (Buroock) Extract, Amica Montana Flower Extract, Boswellia Carteni Resin Extract Calendu Officinalis Extract, Camellia Sinensis Leaf Extract,Camphor; CartJomer,FD&C Blue #1,FD&C Yellow #5,Glycenn,llex Paraguanensis (Mate) Leaf Extract oopropyf /Jcoh , oopropyf Myristafe,Melissa Officinalis (LemooBalm)Leaf Extract, Silica,T=heryf Acetate,Tnethanolamine,water,Whole Hemp Extract

Section 51945-4

Section 55105-1

Topical Analgesic


Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Active Ingredient (55106-9)

Menthol ................ 6%

Indications and Usage (34067-9)

Temporary relief from minor aches and pains of muscles and joints associated with arthritis,simple backache,strains and sprains.

Dosage and Administration (34068-7)

Directions: Adult and children 2 years of age and older. Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age consult a physician

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center immediately

Section 50566-9 (50566-9)

Stop use and ask doctor if condition worsens or symptoms persist for more than 7 days, or clear up and reoccur a gain within few days.

Section 50567-7 (50567-7)

When using this product • avoid contacts with the eyes Of mucous membranes • do not apply to wounds or damaged skin • do not apply to irritated skin • do not bandage • wash hands after use with cool water • do not use with heating pad or device.

Section 51727-6 (51727-6)

Inactive ingredients /Joo Barbadensis Leaf Extract,Arcium Lappa Roof (Buroock) Extract, Amica Montana Flower Extract, Boswellia Carteni Resin Extract Calendu Officinalis Extract, Camellia Sinensis Leaf Extract,Camphor; CartJomer,FD&C Blue #1,FD&C Yellow #5,Glycenn,llex Paraguanensis (Mate) Leaf Extract oopropyf /Jcoh , oopropyf Myristafe,Melissa Officinalis (LemooBalm)Leaf Extract, Silica,T=heryf Acetate,Tnethanolamine,water,Whole Hemp Extract

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical Analgesic


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)